Device Recall FiberOptix Ultra 8 IAB

Batch: 18F14A0031 18F14A0032 18F14A0033 18F14D0066 18F14E0018 18F14E0072 18F14F0067 18F14F0079 18F14G0045 18F14G0046 18F14G0081 18F14H0037 18F14J0023 18F14L0014 18F14M0033 18F15A0010 18F15B0015 18F15C0004 18F15C0023 18F15D0025 18F15D0052 18F15E0020 18F15F0002 18F15F0039 18F15G0005 18F15G0015 18F15H0006 18F15H0037 18F15H0051 18F15J0026 18F15L0007 18S14G0046

Cardiovascular Devices

2

No

Worldwide Distribution: US (Nationwide) and countries of: Argentina, Australia, Belgium, Brunei Darussalam, Brazil, Bahamas, Canada, Chile, China, Colombia, Ecuador, Guatemala, Hong Kong, Indonesia, India, Japan, Korea (Republic of [South] Korea), Myanmar, Mexico, Malaysia, Nepal, New Zealand, Panama, Peru, Philippines, Pakistan, Singapore, Thailand, Trinidad and Tobago, Taiwan, Uruguay, Viet Nam, and South Africa (Zuid Afrika).

FiberOptix Ultra 8 IAB: 8Fr 30cc || The Arrow¿ IAB is utilized for intraaortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.